Philips North America recalled 1,913,441 IntelliVue MP60 monitors on October 31, 2025. The monitors may fail to alarm, posing a significant risk to patient safety. Affected devices were distributed worldwide, including the United States and multiple countries.
Potential issue where the IntelliVue monitors did not alarm.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips North America Llc or your healthcare provider for instructions. Notification method: Letter
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The IntelliVue MP60 has the product number M8005A and UDI-DI 00884838000186. The recall affects all serial numbers of the product. The monitors were sold worldwide.
The IntelliVue monitors may not alarm when needed, potentially leading to undetected medical emergencies. This hazard classifies the recall as Class II, indicating a moderate risk.
There have been no reported injuries or deaths associated with this recall. The absence of alarms poses a serious risk, but no specific incident counts are available.
Patients and healthcare providers should immediately stop using the IntelliVue MP60 monitors. Contact Philips North America or your healthcare provider for further instructions.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0855-2026. Philips North America's contact number is available on their official website.
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